Biomedical Product Development: Bench to Bedside (Learning Materials in Biosciences)

✍ Scribed by Babak Arjmand (editor), Moloud Payab (editor), Parisa Goodarzi (editor)

• Publisher: Springer
• Year: 2020
• Tongue: English
• Leaves: 164
• Edition: 1st ed. 2020
• Category: Library

✦ Synopsis

This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice.

It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations.

The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products.

This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.

✦ Table of Contents

Preface
Contents
Editors and Contributors
Contributors
List of Abbreviations
1: An Introduction to Biomedical Product Development
References
2: Basic Essentials and Applications of Quality Management System (QMS) in Biomedical Sciences
2.1 What You Will Learn in This Chapter
2.2 Rationale and Importance
2.3 A Snapshot of the Quality Management System
2.3.1 The Definition of the Quality Management System
2.3.2 Quality Management System Principles in Biomedical Sciences
2.4 An Introduction to International Organization for Standardization
2.5 International Quality Standards for Laboratories
2.6 Implementing of Safety Management Programs
2.7 Personnel Training Program
2.8 Quality Control Processes
2.9 Quality Assurance
2.10 Monitoring Based on the Quality Management System
2.11 Continuous Improvement
2.11.1 Implementing Tools for Process Improvement
2.11.1.1 External and Internal Audit
2.12 Good Customer Services
2.13 Organizational Requirements and Functions of the Quality Management System
2.14 Documentation
2.15 Challenges and Future Perspectives
References
Further Reading
Books
Online Resources
3: Principles of Good Laboratory Practice (GLP)
3.1 What You Will Learn in This Chapter
3.2 Rationale and Importance
3.3 Good Laboratory Practice (GLP)
3.3.1 An Overview of General Rules
3.3.2 Good Laboratory Practice Training
3.4 Biosafety Concepts in the Laboratory
3.5 Good Microbiological Techniques
3.6 Laboratory Equipment
3.6.1 General Equipment
3.6.2 Safety Equipment
3.6.2.1 Biological Safety Cabinets (BSCs)
3.6.2.2 Pipetting Aids, Homogenizers, Sonicators, and Specimen Containers
3.6.2.3 Personal Protective Equipment and Clothing
3.7 Safety Against Fire, Electrocution, and Chemicals
3.8 Biosafety Instruction
3.8.1 Assessment of Microbiological Hazards
3.8.2 The Importance of Proper Documentation
3.8.3 Standard Operating Procedures (SOPs)
3.8.4 Guidelines for Basic Laboratories: Biosafety Levels 1 and 2
3.8.5 Guidelines for Containment Laboratories: Biosafety Level 3
3.8.6 Guidelines for Maximum Containment Laboratories: Biosafety Level 4
3.8.7 Guidelines on Laboratory Animal Facilities
3.8.8 Guidelines for Laboratory Commissioning
3.9 Safety Checklist
3.10 Challenges and Future Perspectives
References
Further Reading
Books
Online Resources
4: Design of Experimental Studies in Biomedical Sciences
4.1 What You Will Learn in This Chapter
4.2 Rationale and Importance
4.3 Experimental Studies in Biosciences
4.4 Principles of Experimental Study Design
4.4.1 General Remarks
4.4.2 Expert Panels
4.4.3 Literature Review
4.4.4 Problem Statement, Objectives, and Hypotheses
4.4.5 Experimental Units
4.4.6 Treatments
4.4.7 Measurements
4.4.8 Sample Size
4.4.9 Developing a Scientific Method
4.4.10 Pilot Studies
4.4.11 Conduct the Research, Analyze Data, and Formulate Conclusions
4.5 Common Concerns in the Design of an Experimental Study
4.5.1 Feasibility
4.5.2 Reproducibility of Results
4.5.3 Vulnerability in Statistical Design
4.5.4 Data Reporting
4.6 Validation of Designed Study
4.6.1 Internal Validity
4.6.2 External Validity
4.7 Challenges and Future Perspectives
References
Further Reading
Articles
Books
5: Preclinical Studies for Development of Biomedical Products
5.1 What You Will Learn in This Chapter
5.2 Rationale and Importance
5.3 Preclinical Study Essentials
5.3.1 Duration of Treatment
5.3.2 Animal Compatibility
5.3.3 Blinding and Measurement Bias
5.3.4 Reproducibility of Results
5.3.5 Sample Size
5.3.6 Personnel
5.3.7 Data Reporting
5.4 Animal Models
5.5 Translational Importance of Animal Models
5.6 Validation Strategies of Preclinical Studies in Biomedical Sciences
5.7 Guidelines and Standards for Preclinical Studies
5.8 Challenges and Future Perspectives
References
Further Reading
Books
6: Principles of Good Manufacturing Practice
6.1 What Will You Learn in This Chapter?
6.2 Rationale and Importance
6.3 Definition
6.4 From Nineteenth Century to Now: History of GMP
6.5 Good Manufacturing Practice Principles
6.6 Good Manufacturing Practice Regulations and Guidelines
6.7 Challenges and Future Perspective
References
Further Reading
Books
Online Resources
7: The Importance of Cleanroom Facility in Manufacturing Biomedical Products
7.1 What You Will Learn in This Chapter?
7.2 Rationale and Importance
7.3 The Definition of Cleanroom
7.4 Purpose and Strategy of a Cleanroom Design for Manufacturing of Biomedical Products
7.5 Contamination Sources
7.6 Contamination Control
7.7 Cleanroom Classification
7.8 Cleanroom Air Flow
7.9 Challenges and Future Perspective
References
Further Reading
Books
Articles
8: Safety Concerns and Requirement of Cell-Based Products for Clinical Application
8.1 What You Will Learn in This Chapter
8.2 Rationale and Importance
8.3 Classification of Risk Factors
8.3.1 Intrinsic Risk Factors
8.3.1.1 Origin of Cells
8.3.2 Characteristics of Cells
8.3.2.1 Differentiation Status
8.3.2.2 Tumorigenicity
8.3.2.3 Proliferation Capacity
8.3.2.4 Lifespan
8.3.3 Extrinsic Risk Factors
8.3.3.1 Lack of the Donor History
8.3.3.2 Contamination
8.3.3.3 Processing and Storage of Human Cell-Based Products
8.3.3.4 Coding and Traceability
8.3.3.5 Cellular Dosage and Regimen
8.3.3.6 Tumorigenecity
8.3.4 Clinical Characteristics
8.3.4.1 Administration Route
8.3.4.2 Immune Response
8.4 Challenges and Future Perspectives
References
Further Reading
9: Standards and Regulatory Frameworks (for Cell- and Tissue-Based Products)
9.1 What You Will Learn in This Chapter?
9.2 Rationale and Importance
9.3 Therapeutic Characterizations of Cell-Based Products
9.4 Governmental Standards
9.5 Standards and Regulations in Different Countries
9.5.1 The United States
9.5.1.1 Tissues
9.5.1.2 Biological Products
9.5.1.3 Medical Devices
9.5.2 Canada
9.5.3 The European Union
9.5.4 Australia
9.5.5 Japan
9.5.6 Korea
9.5.7 Singapore
9.6 The Current International Standards and Regulatory Frameworks
9.7 Challenges and Further Perspectives
References
Further Reading
Articles
Online Sources
10: Principles of Good Clinical Practice
10.1 What You Will Learn in This Chapter
10.2 What Is Good Clinical Practice?
10.3 History of GCP
10.4 Rationale and Importance
10.5 Principles of GCP Guidance
10.6 Major Stakeholders of the GCP Protocol
10.7 GCP around the World
10.8 Challenges and Future Direction
References
Further Reading
Books
Online Resources
11: Design, Performance, and Monitoring of Clinical Trials
11.1 What You Will Learn in This Chapter?
11.2 What Are Clinical Trials?
11.3 Rationale and Importance
11.4 Phases of Clinical Trial
11.4.1 Phase I
11.4.2 Phase II
11.4.3 Phase III
11.4.3.1 Basic Principles
11.4.3.2 Features of the Participants in Trial Groups
11.4.3.3 Premature Termination
11.4.4 Phase IV
11.5 Statistics in Clinical Trial Design
11.5.1 Alternative Hypothesis
11.5.2 Null Hypothesis
11.5.3 Intent to Treat (ITT)
11.5.4 Type I Error (α)
11.5.5 Type II Error (β)
11.6 Eligibility Criteria and Intervention
11.6.1 Inclusion and Exclusion Criteria
11.6.2 Intervention
11.6.2.1 Treatment
11.6.2.2 Prevention
11.6.2.3 Diagnostics
11.6.2.4 Supportive Care
11.6.2.5 Health Services Research
11.6.2.6 Basic Science
11.7 Clinical Trial Monitoring
11.7.1 Risk Assessment
11.7.1.1 Risk Identification
11.7.1.2 Risk Analysis
11.7.1.3 Risk Evaluation
11.7.2 Clinical Trials Registration
11.8 Challenges and Future Direction
11.8.1 Eligible Patient Enrollment
11.8.2 During the Trials
11.8.2.1 Cost of Trials
11.8.2.2 Long Time Span
References
Further Reading
Online Resources
Books
12: Good Clinical Practice: Guidelines and Requirements
12.1 What You Will Learn in This Chapter
12.2 Rationale and Importance
12.3 Features of Good Clinical Practice
12.3.1 Institutional Review Board/Independent Ethics Committee (IRB/IEC)
12.3.2 Investigator
12.3.3 Sponsor
12.3.4 Monitor
12.3.5 Informed Consent
12.4 Provisions and Prerequisites to Proceed with a Clinical Trial
12.4.1 Justification of Clinical Research
12.4.2 Essential Documents for Conducting a Clinical Trial
12.4.2.1 Case Report Form
12.4.2.2 Investigator’s Brochure
12.5 Protocol of Clinical Study
12.5.1 General Information
12.5.2 Background and Summary
12.5.3 Objectives and Design of the Trial
12.5.4 Inclusion and Exclusion Criteria
12.5.5 Treatment and Intervention
12.5.6 Safety and Efficacy Evaluation
12.6 Risk Management
12.7 Challenges and Future Direction
References
Further Reading
Books
Online Resources
13: Ethical Considerations of Biomedical Product Development
13.1 What You Will Learn in This Chapter
13.2 Rationale and Importance
13.3 Conceptual Framework of Research Ethics in Biomedicine
13.4 Philosophy of Research Ethics in Biomedicine
13.5 History of Research Ethics
13.6 Research Ethics Committee
13.7 Research Ethics in the Use of Animals in Biomedicine
13.8 Research Ethics Involving Human Experiments
13.8.1 Informed Consent
13.8.2 Privacy and Confidentiality
13.8.3 Use of Placebo in Clinical Trials
13.9 Research Ethics on Vulnerable Groups
13.10 Research Ethics in Special Areas
13.11 Challenges and Future Perspectives
Appendix 1. The Nuremberg Code (1947)
Appendix 2. Declaration of Helsinki (1975)
Introduction
I Basic principles
II Medical research combined with professional care (clinical research)
III Non-therapeutic biomedical research involving human subjects (non-clinical biomedical research)
Appendix 3. Guidelines for Ethical Conduct in the Care and Use of Animals
I. General
II. Personnel
III. Facilities
IV. Acquisition of Animals
V. Care and Housing of Animals
VI. Justification of the Research
VII. Experimental Design
VIII. Experimental Procedures
IX. Field Research
X. Educational Use of Animals
XI. Disposition of Animals
References
Further Reading
Correction to: Biomedical Product Development: Bench to Bedside, Learning Materials in Biosciences
Correction to: B. Arjmand et al. (eds.), Biomedical Product Development: Bench to Bedside, Learning Materials in Biosciences, 7 https://doi.org/10.1007/978-3-030-35626-2
Index